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Lead Quality Assurance Specialist
3 weeks ago
Job Summary
The Quality Control Microbiologist plays a crucial role in ensuring the microbiological quality of products, manufacturing equipment, and facility utilities. This position requires strong attention to detail, excellent written and oral communication skills, and the ability to work independently or as part of a team.
Main Responsibilities:
- Perform testing to ensure compliance with regulatory standards in the manufacturing facility.
- Assess the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
- Enter laboratory clean-rooms to collect and log samples for microbial analysis.
- Perform bioburden and endotoxin sample analysis in line with standard operating procedures (SOPs).
- Perform sample analysis for microbial identification.
- Perform environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
- Perform acceptance testing of commercially prepared microbiological culture media.
- Autoclaving microbiological media and laboratory waste as needed.
- Evaluate all work to ensure compliance with regulatory standards, company policies, and SOPs.
- Complete test records on time and peer review data from other analysts for accuracy and completeness.
- Assist in the design and setup of the QC microbiology laboratory and select, implement, and calibrate laboratory instruments.
- Participate in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs.
- Assist manufacturing personnel in identifying microbiological root causes and provide technical advice as needed.
- Participate in the transfer of methodologies from other test facilities.
- Maintain laboratory reagents, media, and supplies.
- Conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT.
- Initiate and complete CAPAs and change controls in adherence with site procedures.
- Communicate analytical data reports clearly and concisely to management.
- Identify and implement lab process improvements and lean initiatives.
Key Requirements:
- Bachelor's degree in Microbiology or related field, or equivalent experience.
- 2+ years of validated experience in a similar role, or equivalent combination of education and experience.
- Strong trouble-shooting and problem-solving skills.
- Excellent written and oral communication skills.
